Enrolling by invitation OBSERVATIONAL NCT07653321

The rung where the data is gathered, before any AI exists — a three-year acute kidney injury registry across 19 intensive care units — a clinical trial (ClinicalTrials.gov)

Beijing Chao Yang Hospital Updated 2026-06-17

A three-year prospective observational registry led by Beijing Chao Yang Hospital, consecutively enrolling 23,600 adult critically ill patients across the intensive care units of 19 tertiary hospitals. It gathers clinical characteristics, time-series monitoring, laboratory values, renal ultrasound, biomarkers and omics data, and retains biological samples. The AI to be evaluated does not yet exist; the models are registered as work still to come.

Trial overview (primary data)

  • StatusEnrolling by invitation
  • ConditionsAcute Kidney Injury
  • InterventionsOTHER: Not applicable- observational study
  • SponsorBeijing Chao Yang Hospital
  • Target enrollment23,600 participants
  • Period2026-05-01 〜 2029-05-01

Key points

  • A prospective observational registry consecutively enrolling 23,600 adult critically ill patients over three years across the intensive care units of 19 tertiary hospitals, with more than 3,000 cases of acute kidney injury expected.
  • The AI under evaluation does not yet exist. Three to five early-warning and prognostic models and one decision-support system are registered as work still to come.
  • Clinical characteristics, time-series monitoring, laboratory values, renal ultrasound, biomarkers and omics data are gathered, with biological samples retained. Only 9 of the 803 records this site holds as of 2026-09-04 (1.1%) mention biological samples.
  • The target of 23,600 sits in the top 3% of the 797 records that state one, but what matters is the breadth of fields, which decides which models can be built later.
  • This describes the aims and plan of the study; effectiveness has not been established.

1A rung that comes before evaluation

When a clinical trial of medical AI is mentioned, what usually comes to mind is a scene in which a finished model has its performance measured. This registration sits before that.

Built on a critical-care specialty alliance approved by the Beijing Hospital Management Center, covering the intensive care units of 19 tertiary hospitals nationwide, it is recorded as a prospective observational study that will enroll adult critically ill patients consecutively over three years.

What is collected is clinical characteristics, time-series monitoring data, laboratory values, renal ultrasound imaging, biomarkers and omics data, with biological samples retained alongside. The AI to be evaluated does not yet exist anywhere.

2Breadth has to be fixed first, because it cannot be added later

Target enrollment for this study23,600Consecutive enrollment across 19 intensive care units over three years, with more than 3,000 cases of acute kidney injury expected
Median target enrollment among the 803 records this site holds as of 2026-09-04200Stated for 797 of them
Records that mention retaining biological samples91.1% of those same 803

A target of 23,600 puts this study in the top 3% of the 797 records that state one. What does the work here, though, is breadth rather than headcount. Unless time-series data, imaging, laboratory values and biological samples come from the same patients, a model somebody wants to build later simply cannot be built.

The list of what gets collected fixes in advance not the models anyone has in mind today, but the range of models anyone might think of three years from now.

3What is planned has been written down

  1. 1Early warningBuild something that catches the signs before acute kidney injury sets in
  2. 2DiagnosisRecapture the condition against standardized criteria
  3. 3PhenotypingSeparate sub-phenotypes using machine learning
  4. 4TreatmentBuild support for decisions about renal replacement therapy
  5. 5PrognosisEvaluate outcomes and turn them into the basis for guidance

The record states an intention to produce three to five early-warning and prognostic models and one decision-support system. Read the other way, none of them exists yet.

The reasoning is set out at the opening of the record: critical care in China lacks standardized, localized specialist data and lacks capacity for early warning and sub-phenotyping, and that shortfall is what constrains the application of artificial intelligence.

4Counting the rung where the material is made

Of the 803 records this site holds as of 2026-09-04, 74 (9.2%) mention a database or data collection itself. Medical AI trials carry, ahead of the rung where performance is measured, a rung where the material that makes measurement possible is built. It looks unglamorous because no accuracy figure comes out of it, yet what later trials will be able to test is settled here.

Choosing acute kidney injury, sudden in onset and easily diagnosed late, likewise only makes sense once a foundation of time-series data is in place.

Why it matters

Evaluating medical AI carries, ahead of the rung where performance is measured, a rung where the material for measurement is built. What is settled there is not accuracy but the range of questions later studies can test. Gathering time-series data, imaging, laboratory values and biological samples from the same patients shows how breadth of data governs later options, which is a useful reference for anyone building a data foundation of their own.

FAQ

Is this not a trial that measures AI performance?
The record states that early-warning and prognostic models and a decision-support system are yet to be produced. No AI is under evaluation at this point; the study is at the stage of gathering the material for one.
Why are so many participants needed?
More than 3,000 cases of acute kidney injury are anticipated, and analyzing sub-phenotypes separately requires a large denominator. Consecutive enrollment across 19 intensive care units follows from that.
Do many studies retain biological samples?
Of the 803 records this site holds as of 2026-09-04, only 9 (1.1%) mention retaining biological samples.

Sources (primary)

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

#Clinical trials#AI#Healthcare#Critical care#Data infrastructure
Disclaimer: This site independently summarizes and classifies information based on official data sources. Always verify the latest and accurate information with the official sources. Content on finance, health, legal, and security is information, not advice. This site is not an official website of the U.S. government.